Theophylline Prophylaxis During Hypothermia to Limit Neonatal Nephron Damage

RECRUITING

I'm interested ...!!

Acute kidney injury is a significant complication for infants who experience hypoxic ischemic encephalopathy, being associated with increased rates of death and prolonged hospitalization. This pilot study of theophylline administration soon after birth for the prevention of kidney injury will lay the foundation for the conduct of a larger clinical trial that seeks to identify a theophylline as a novel therapy to prevent kidney injury in thousands of at-risk infants.

Conditions:

🦠 Acute Kidney Injury 🦠 HIE

🗓️ Study Start (Actual) 17 October 2023

🗓️ Primary Completion (Estimated) 1 April 2026

✅ Study Completion (Estimated) 1 April 2027

👥 Enrollment (Estimated) 54

🔬 Study Type INTERVENTIONAL

📊 Phase PHASE1

Locations:

📍 Oklahoma City, Oklahoma, United States

📋 Eligibility Criteria

Description

Inclusion Criteria:

* gestational age at birth \>= 35 weeks by best obstetrical dating
* birth weight \> 1800 grams
* clinical determination of HIE and treatment with hypothermia being initiated within six hours of birth according to institutional guidelines
* no known congenital abnormalities involving the brain, kidneys, heart or lungs
* ability to administer theophylline via intravenous route within 12 hours of birth

Exclusion Criteria:

* infants with suspected or diagnosed significant renal, urinary tract, brain, heart, or lung abnormalities
* infant with known chromosomal anomaly
* evidence of head trauma or skull fracture causing major intracranial hemorrhage
* inability to initiate hypothermia within six hours of birth
* attending physician unwilling to have infant participate in the study
* inability to obtain informed consent within 12 hours of birth

Ages Eligible for Study: 1 Hour to 12 Hours (CHILD)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 20 March 2023
First Submitted that Met QC Criteria 2 May 2023
First Posted 11 May 2023

Study Record Updates

Last Update Submitted that Met QC Criteria 17 October 2023
Last Update Posted 19 October 2023
Last Verified October 2023